O'Brien to head AMC clinical-trials unit

AMC Health, a US-based provider of ‘end-to-end’ telehealth solutions, has named Michael O'Brien as president of its new Clinical Trials Division.

The diversification is in response to “surging demand” for innovative telemonitoring offerings in clinical drug development, AMC Health said.

It cited the recent approval by the US Food and Drug Administration of a Phase II trial looking at the antihypertensive lisinopril as an adjunctive therapy for multiple sclerosis.

In the study run by Transparency Life Sciences (TLS), a US-based biopharmaceutical concern that uses open-innovation techniques to design and deliver clinical trials involving ‘repurposed’ off-patent compounds, most of the biometric and patient-reported outcomes will be collected through AMC Health’s telemonitoring platform.

TLS partnership

Under its partnership with TLS, data on blood pressure and heart rate, mobility, physical and mental function, symptoms, side effects, quality of life and medication adherence will be gathered direct from patients’ homes in the lisinopril trial.

According to TLS’s chief executive officer (CEO), Tomasz Sablinski, the use of telemonitoring will reduce the cost of the lisinopril study by more than 50%, AMC Health pointed out.

The company is also providing telemonitoring services for a Phase 1 study of a “new drug in development by a major pharmaceutical company”, it said.

30 years’ experience

In taking on the new role, O'Brien will leverage 30 years of broad-based C-suite experience in the life sciences and information technology industries, AMC Health observed.

O’Brien was previously president and CEO of Beardsworth Consulting Group, a specialist contract research organisation based in the US and acquired by TFS International in April.

Pharmaceutical companies have faced “real challenges” in enrolling and retaining clinical-trial participants, collecting accurate data, and analysing and reporting the results, observed Nesim Bildirici, president and CEO of AMC Health.

The use of innovative telemonitoring technology in this context will “transform drug development in an industry that is poised to take advantage of its many benefits”, Bildirici said.

Time and costs

With strong incentives to cut the time and costs associated with drug development, the capacity of telemonitoring to “revolutionise all facets of the clinical trial process: recruitment, data capture and data analysis, make it a game changer”, AMC Health maintained.

For example, average medication-adherence rates in clinical trials are only 43% to 78%, according to the New England Journal of Medicine.

Telemonitoring “can alert patients and researchers when medications are not taken as directed, which can significantly improve the rate of adherence”, AMC Health said.

Another application is in automating data collection. Traditionally, clinical-trial data have been gathered and inputted manually, “which is inefficient and error-prone”, the company noted.

With telemonitoring, data are uploaded directly from in-home biometric monitors, so “there is less need to audit and monitor the data-collection process”.